FDA-Drug2018-11-21Class III
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Takeda Development Center Americas, Inc.
Hazard
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Sold states
Product was distributed to 32 distributors throughout the United States.
Affected count
69,075 60-count bottles (4,144,500 capsules)
Manufactured in
1 Takeda Pkwy, 4034BB1, Deerfield, IL, United States
Products
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2019Don't want to check this manually?
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